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Preparing Industry Proposals and Budgets

Preparing Industry Proposals and Budgets. Scott Davis, CRA Associate Director Office of Research Administration University of Oklahoma Health Sciences Center. Research Type Industry funded research Pfizer, GlaxoSmithKline, etc. Private funded research American Heart, Komen, etc.

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Preparing Industry Proposals and Budgets

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  1. Preparing Industry Proposals and Budgets Scott Davis, CRA Associate Director Office of Research Administration University of Oklahoma Health Sciences Center

  2. Research Type • Industry funded research • Pfizer, GlaxoSmithKline, etc. • Private funded research • American Heart, Komen, etc. • No direct Federal Funding

  3. Workflow • PI identifies funding • PI prepares the proposal/SOW • RESEARCH OFFICE REVIEWS PROPOSAL • Award • Award reporting and close-out

  4. Will not be discussing • Contract Language • Clinical Trials

  5. Differences with Federal Grants • Approve terms in advance • Allowable Costs • Allowable IDC

  6. Problematic Areas • Cost share • Reduced or no F&A • Non-negotiable terms • One application per Institution • CDA

  7. Instructions • Guidelines • Budget • IDC • Same Information / Different Forms • Different from NIH • Read and Follow All Application Instructions!

  8. Review Process • What’s Needed • Required Institutional Paperwork • Copy of Guidelines • Statement of Work (SOW) • Budget • Research Agreement • Review guidelines

  9. Required Institutional Paperwork • Routing form • Cost Share Approval • COI forms • IDC Exceptions • IACUC/IRB

  10. Guidelines • Review • Requirements to apply • Restrictions • 501 c3 • No tobacco funding • IDC • IP

  11. Statement of Work (SOW) • Formal document that defines: • Work Activities • Deliverables • Timeline must execute in performance of specified work for a client. • Includes: • Requirements • Pricing • Regulatory and governance terms and conditions http://en.wikipedia.org/wiki/Statement_of_work

  12. SOW Components • Description of work being performed • Location • Period of performance • Publication • Scientific input • Invention • Budget

  13. SOW Bad Example • I will be reviewing square pieces of glass containing some goo. I will report to the guy in charge of the results.

  14. SOW Good Example • EGG NOG expert pathology reviewers are assigned to active EGG NOG study protocols for confirming institutional diagnoses, to assess relevant enrollment criteria, for assigning subtypes of tumors to the appropriate protocol arms, and for validating the suitability of tumor tissues for biology-based studies. Reviewers will assess materials provided to them and return their reviews in a timely fashion to the EGG NOG Biopathology Center.

  15. Budget • Industry or Private Funding • Simple or Detailed • Fixed Price or Cost Reimbursable

  16. Fixed Price vs. Cost Reimbursable • Fixed Price operate under an established price that cannot be revised. • Cost-Reimbursable sponsored projects allow costs to be expended up to a set amount.

  17. Cost Reimbursable Advantages • No incentive to cut corners • Quality vs. time • Less risk • Cost Reimbursable Disadvantages • Sponsor requires more financial reporting • Refund unused funds • Less incentive to be efficient • http://govwin.com/knowledge/cost-reimbursement

  18. Fixed Price Advantages • Know total price upfront • Best interest to Control Cost • Leftover money to PI/Department • Fixed Price Disadvantages • No Price Adjustments • Maximum risk

  19. Contract or No contract

  20. Receive Award without Prior Review • Game plan • Start process as if new

  21. Reasons for No Prior Review • Small amount we don’t need a contract • No IDC/F&A lead to larger studies • Competing against other Universities

  22. Do I need Contract/Budget? Why? • A contract is a legally enforceable agreement • Creates binding obligations, rights and duties for each party • Payment of money • Institution has a legal obligation to protect its personnel, assets and resources • Institution must ensure that it limits its liability • Comply with the terms in the contract

  23. Comply with state and federal laws and regulations • Contracts submitted for Institutional Approval • Office of Research Administration • Legal Office • Office of Technology Development • IACUC • IRB • Department

  24. Questions?

  25. Thank You for Your Participation Scott Davis Associate Director Office of Research Administration The University of Oklahoma Health Sciences Center P 405-271-2090 Scott-Davis@ouhsc.edu

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